A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily - Full Text View

Sponsor:	Intendis GmbH
Information provided by:	Intendis GmbH
ClinicalTrials.gov Identifier:	NCT00417937

Purpose

To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.

Condition	Intervention	Phase
Papulopustular Rosacea	Drug: azelaic acid 15% gel	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice Daily in Subjects With Papulopustular Rosacea

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Azelaic acid

U.S. FDA Resources

Further study details as provided by Intendis GmbH:

Primary Outcome Measures:

Investigator's global assessment scored on a seven point scale [ Time Frame: Measurements made during the course of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy [ Time Frame: Parameters measured during the course of treatment ] [ Designated as safety issue: No ]

Enrollment:	98
Study Start Date:	January 2007
Study Completion Date:	June 2007

Arms	Assigned Interventions
Active Comparator: 1 Azelaic acid 15 % gel once daily	Drug: azelaic acid 15% gel 15% gel, topically applied once daily for six weeks
Active Comparator: 2 Azelaic acid 15 gel twice daily	Drug: azelaic acid 15% gel 15% gel, topically applied twice daily for six weeks

Detailed Description:

To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules

Exclusion Criteria:

Mild or severe rosacea
Rosacea with marked ocular manifestations
Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course
Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia
History of hypersensitivity to propylene glycol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417937

Locations

Germany
Intendis GmbH
Berlin, Germany

Sponsors and Collaborators

Intendis GmbH

Investigators

Study Director:

Intendis GmbH

More Information

Additional Information:

(Click here and search for drug information provided by the FDA) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Klaus Graupe/Senior Medical Advisor, Intendis GmbH
ClinicalTrials.gov Identifier:	NCT00417937 History of Changes
Other Study ID Numbers:	1401460
Study First Received:	January 2, 2007
Last Updated:	December 3, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Rosacea
Skin Diseases
Azelaic acid
Dermatologic Agents

Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012